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临床试验/NCT07695662
NCT07695662尚未招募不适用

The Predictive Value of Increased Lower Limb Muscle Tone on Neurogenic Detrusor Overactivity in Patients With Spinal Cord Injury: A Retrospective Analysis

Shengjing Hospital0 个研究点目标入组 300 人开始时间: 2026年7月7日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
300
主要终点
Presence of Neurogenic Detrusor Overactivity Confirmed by Urodynamic Study

研究概览

简要总结

The goal of this observational study is to evaluate whether increased lower extremity muscle tone can serve as an independent predictor of neurogenic detrusor overactivity (NDO) in adult patients (aged 18-80 years) with upper sacral spinal cord injury .

The main questions it aims to answer are:

Is increased lower extremity muscle tone independently associated with the presence of detrusor overactivity after adjusting for age, sex, injury level, injury type, and injury cause?

Does the predictive value of muscle tone for detrusor overactivity differ across subgroups defined by injury level, injury severity, and time since injury?

Researchers will compare patients with lower extremity hypertonia (Modified Ashworth Scale ≥ 1) to patients with normal muscle tone (Modified Ashworth Scale = 0) to see if muscle tone elevation independently predicts detrusor overactivity.

Participants will not be asked to do anything beyond their routine clinical care, as this is a retrospective study that only collects data from existing medical records, including neurological examination results, Modified Ashworth Scale scores, and urodynamic study reports.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
16 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of spinal cord injury confirmed by CT or MRI imaging
  • Suprasacral spinal cord injury according to the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI, 2011 revision)
  • Age between 18 and 80 years
  • Complete medical records, including detailed neurological examination, Modified Ashworth Scale assessment, and urodynamic study report

排除标准

  • Critical missing information in medical records or urodynamic reports
  • Interval between Modified Ashworth Scale assessment and urodynamic study exceeding 2 weeks

结局指标

主要结局

Presence of Neurogenic Detrusor Overactivity Confirmed by Urodynamic Study

时间窗: Baseline (At hospital admission)

Neurogenic detrusor overactivity (NDO) is defined as the presence of involuntary detrusor contractions during the filling phase of a urodynamic study, according to International Continence Society (ICS) standards. Urodynamic studies were performed as part of routine clinical care during the hospital admission. This outcome measures the presence or absence of NDO based on the urodynamic report. The result is reported as a binary outcome (present/absent).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Xue Jiang

Associate Professor

Shengjing Hospital

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